NOSTRILLA- oxymetazoline hydrochloride spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)

Available from:

Insight Pharmaceuticals LLC

INN (International Name):

Oxymetazoline Hydrochloride

Composition:

Oxymetazoline 0.0005 mL in 100 mL

Administration route:

NASAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal decongestant - temporarily relieves nasal congestion due to: ▪ a cold ▪ hay fever ▪ upper respiratory allergies ▪ helps clear nasal passages; shrinks swollen membranes ▪ temporarily restores freer breathing through the nose

Authorization status:

OTC monograph final

Summary of Product characteristics

NOSTRILLA- OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED
INSIGHT PHARMACEUTICALS LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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NOSTRILLA
_DRUG FACTS_
_ACTIVE INGREDIENT (PER SPRAY)_
oxymetazoline hydrochloride 0.05%
_PURPOSE_
Nasal decongestant
USES
temporarily relieves nasal congestion due to:
▪ a cold
▪ hay fever
▪ upper respiratory allergies
▪ helps clear nasal passages; shrinks swollen membranes
▪ temporarily restores freer breathing through the nose
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
WHEN USING THIS PRODUCT
DO NOT EXCEED RECOMMENDED DOSAGE
temporary discomfort such as burning, stinging, sneezing, or an
increase in nasal
discharge may occur
do not use for more than 3 days. Use only as directed. Frequent or
prolonged use
may cause nasal congestion to recur or worsen.
use of this container by more than one person may spread infection
STOP USE AND ASK A DOCTOR IF
symptoms persist
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)
right away.
DIRECTIONS
ADULTS AND CHILDREN 6 TO UNDER 12 YEARS OF AGE (with adult
supervision): 2 or 3
sprays in each nostril not more often than every 10 to 12 hours. Do
not exceed 2
doses in any 24 hour period
CHILDREN UNDER 6 YEARS OF AGE: ask a doctor
Squeeze and unscrew to remove the protective cap. Align rail grooves
and prime pump
by depressing it firmly several times (see illustration on side). Hold
bottle with thumb at
base and nozzle between first and second fingers. With head upright,
insert nozzle into
nostril. Depress pump two or three times, all the way down, and sniff
deeply.
OTHER INFORMATION
store between 20° – 25°C (68° – 77°F). A